CTRI/2011/12/002229已完成3 期
A Dose-Frequency Blinded, Multicenter, Extension Study to determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen Idec
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated
- •informed consent and authorization to use protected health information in
- •accordance with national and local subject privacy regulationsSubjects who participated in Study 105MS301 who completed the study treatment and
- •visit schedule through Week 96
- •Subjects of childbearing potential must practice effective contraception during the study
- •and be willing and able to continue contraception for 3 months after their last dose of
- •study treatment.
排除标准
- •Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study
- •Subjects with any significant change in medical history, including laboratory tests or a
- •current clinically significant condition that in the opinion of the Investigator would have
- •excluded the subject from participation in Study 105MS301. The Investigator must
- •re-review the subject�s medical fitness for participation and consider any factors that
- •would preclude treatment including
- •ï¿½ Presence of any clinically significant as determined by the Investigator cardiac
- •endocrinologic hematologic hepatic immunologic metabolic urologic pulmonary
- •neurologic dermatologic psychiatric renal or other major disease that would preclude
- •participation in a clinical study
- •Presence of malignant disease, including solid tumors and hematologic malignancies
- •with the exception of basal cell and squamous cell carcinomas of the skin that have
- •been completely excised and are considered cured
- •Clinically significant laboratory abnormalities hematology and blood chemistry on
- •the most recently available test of Study 105MS301 as determined by the Investigator.
- •Laboratory findings mandating discontinuation of study treatment as defined in
- •protocol 105MS301 are exclusionary.
- •3. Female subjects who are currently pregnant as reflected by a positive pregnancy test at
- •the Week 96 Visit of Study 105MS301 Baseline Visit who are currently breastfeeding
- •or who are considering becoming pregnant while in the study
- •4. Unwillingness or inability to comply with the requirements of the protocol including the
- •presence of any condition physical mental or social) that is likely to affect the subjects
- •ability to comply with the protocol.
- •Other unspecified reasons that in the opinion of the Investigator or Biogen Idec make
- •the subject unsuitable for enrollment.
研究者
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